Senior Clinical Development Leader (RAVE)
The Senior Principal Clinical Database Developer will provide oversight and improve the integrity of our clinical database systems. This position will build harmonization and standardization of clinical databases across clinical studies. Through forward-thinking improvements and positively working with various teams, this role will ensure the quality of our clinical data systems.
- Accountable for oversight on standardization and harmonization of clinical database activities across clinical projects
- Provides project level technical expertise to Clinical Project Teams, data management, medical, analysis and reporting and study management teams throughout all study start up activities
- Works with representatives of other technical groups, data management, analytics and reporting to define harmonized requirements for delivering clinical studies
- Works closely with the standards group for defining and maintaining standards for clinical database development
- Ensures compliance to GCP, GAMP and other global guidelines in delivering clinical databases
- Provides new insights to solve complex programming requirements
- Governs the Clinical Data Management Systems global and program standards libraries
- Leads projects to automate, simplify and innovate in order to ensure that the team is industry leading
- Supports the organization in defining the digital strategy for delivering future CDD activities
- Accountable for delivering CDD activities within budget
- Accountable for appropriate resourcing and training of reporting teams
- May act as backup for the Head of Clinical Database Development
- Mentor and train Database Developers
- Bachelor's degree, preferably in computing or scientific area
- 10+ years database development experience in the pharmaceutical industry working with clinical trial data.
- 5+ years line management experience
- Experience in working with matrix organizations
- Excellent Clinical trial knowledge
- Excellent organizational and analytical skills and high attention to detail
- Excellent written and verbal communication skills, organized and ability to lead tasks from concept to delivery
- Excellent planning, resource and project management skills.
- Solid understanding of clinical data system design / development / validation and system interoperability.
- Ability to work independently without close supervision
About AstraZeneca Canada:
Our purpose is bold and so is our approach. Becoming a more agile and innovative company means creating a vibrant, dynamic culture where we celebrate entrepreneurial thinking and act quickly to inspire change. We are courageous, taking smart risks and learning from both success and failure. We are curious, creative, and open to new insights and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us at our great place to work; an environment that energizes and empowers each of us to achieve our goal to develop and deliver medicines.
Great People want to Work with us! Find out why:
- GTAA Top Employer Award for 6 years: https://reviews.canadastop100.com/top-employer-astrazeneca-canada
- Best Workplace Culture Award at the 2018 Canadian HR Awards: https://www.linkedin.com/pulse/thriving-best-workplace-culture-gena-restivo/
- Learn more about our culture: https://www.linkedin.com/posts/genarestivo_greatpeople-greatplacetowork-topemployers2020-activity-6608742174811049985-N-8G
Are you interested in working at AZ? Apply today!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.